Biomarkers and Companion Diagnostics in Oncology

Next-generation sequencing will shape the companion diagnostics market in the next five years,says GlobalData

The global companion diagnostics (CDx) market will be shaped by next-generation sequencing (NGS) technologies over the next five years, according to GlobalData, a leading data and analytics company.

The company’s latest report: ‘Biomarkers and Companion Diagnostics in Oncology’ states that one of the most important drivers of the market for CDx will be the increased emphasis on cost-effective healthcare.

Fern Barkalow, PhD, Oncology and Hematology Director at GlobalData, says: “Measuring many biomarkers in one test using NGS panels will become increasingly important as targeted therapies continue to become embedded in treatment algorithms for many different types of cancer.

“This technology is likely to transform the companion diagnostics market in the next five years due to its high efficiency and gradually decreasing cost. There are currently five marketed next-generation sequencing CDx in the US, the first of which was approved in 2016.”

GlobalData’s analysis also finds that the US leads the way in terms of clarity on CDx regulation.

Barkalow continues:“The FDA’s guidance is stringent regarding analytical and clinical validity, but it does facilitate CDx market entry by providing multiple marketing authorization pathways, and the agency is pursuing tighter regulation of laboratory-developed tests. CDx regulation in Japan is less advanced than in the US in certain aspects, while CDx were only recently formally defined in Europe and remain undefined in China in terms of regulatory processes.”

Roche will be a major player in the global CDx market, due in part to its recent acquisition of Foundation Medicine.

Barkalow concludes,“Roche currently has the highest number of marketed CDx products in the US and Japan, including those developed by its subsidiary companies Ventana Medical Systems and Foundation Medicine. Altogether, Roche owns 31% of the products on the US market. In addition, Foundation Medicine has existing CDx partnerships with other companies such as Merck and AstraZeneca, from which Roche now stands to benefit financially.”